Senior Clinical Research Coordinator — Lead & Mentor

ECN Clinical; Denver (CO); On-site; USD 70,000 - 110,000; Full time

Job summary

ECN Clinical is seeking a Lead Clinical Research Coordinator to manage day-to-day operations of clinical studies at the Denver site. The role includes leadership, protocol adherence, data integrity, and study monitoring to ensure inspection readiness.

The Lead CRC will mentor coordinators, coordinate start-up through close-out, and liaise with sponsors and regulatory bodies while ensuring HIPAA and GCP compliance.

Qualifications

• Bachelor’s degree in health sciences or related field required.
• CCRC or equivalent certification preferred and beneficial.

Responsibilities

• Coordinate and manage clinical research protocols from start-up to close-out.
• Recruit, screen, consent, and enroll participants in compliance with protocols and ethics.
• Collect, record, and maintain accurate data and source documentation.
• Schedule and conduct study visits per protocol and ICH-GCP standards.
• Prepare and submit IRB submissions, amendments, continuing reviews, and AE reports.
• Ensure timely data entry into electronic data capture (EDC) systems.
• Serve as the primary point of contact for sponsors, CROs, monitors, and regulators.
• Maintain regulatory binders and ensure FDA and GCP compliance.
• Monitor study inventory and order supplies as needed.
• Support audit readiness and participate in monitoring visits and inspections.
• Mentor and onboard coordinator staff; oversee workload and timelines.
• Review data quality and support escalation processes as needed.

Skills

Detail orientation

Organizational skills

Communication

Microsoft Office

HIPAA knowledge

Education

Bachelor’s degree in health sciences

CCRC certification (or equivalent) preferred

Tools

REDCap

Medidata

Job description

ECN Clinical is seeking a Lead Clinical Research Coordinator to manage day-to-day operations of clinical studies at the Denver site. The role includes leadership, protocol adherence, data integrity, and study monitoring to ensure inspection readiness.

The Lead CRC will mentor coordinators, coordinate start-up through close-out, and liaise with sponsors and regulatory bodies while ensuring HIPAA and GCP compliance.